Advanced MalignanciesPhase 1/2NCT03277352
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
A Phase 1/2 study testing INCAGN01876, Epacadostat and Pembrolizumab in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Metastatic Cancer
- What is being tested?
- INCAGN01876, Epacadostat and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2017to 1 Jul 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Who cannot join
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
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- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
About this study
Official title: A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Being tested
- INCAGN01876, Epacadostat, Pembrolizumab
- Keywords
- cervical cancer, endometrial cancer, gastric cancer (including stomach and gastroesophageal junction (GEJ)), esophageal cancer, hepatocellular carcinoma (HCC), melanoma (mucosal or cutaneous), Merkel cell carcinoma, mesothelioma, microsatellite instability-high (MSI-H), solid tumors, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), urothelial carcinoma, glucocorticoid-induced tumor necrosis factor receptor (GITR)
- Medical subject headings
- Neoplasm Metastasis, Uterine Cervical Neoplasms, Endometrial Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Melanoma, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN01876Drug
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
EpacadostatDrug
Also called INCB024360
Epacadostat will be self-administered orally at the protocol-defined dose.
PembrolizumabDrug
Also called Keytruda®
Pembrolizumab will be administered IV at the protocol-defined dose.
| Study group | Role | What they receive |
|---|---|---|
| INCAGN01876 + Pembrolizumab + Epacadostat | Experimental | INCAGN01876 in combination with pembrolizumab and epacadostat Receives: Drug: INCAGN01876; Drug: Epacadostat; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Measured: Screening through 60 days after end of treatment, up to approximately 18 months
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary outcomes (5)
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
Defined as time from first report of SD or better until disease progression or death from any cause.
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Measured: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Overall Survival
Defined as the time from the start of combination therapy until death due to any cause.
Measured: At 1 year and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start21 Nov 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: The study was terminated due to emergent data from another study and unrelated to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John N. Janik, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277352
- Sponsor's protocol ID
- INCAGN 1876-202
- Status last verified
- Jun 2021
- First submitted
- 14 Aug 2017
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
- ClinicalTrials.gov ID
- NCT03277352
- Acronym / sponsor ID
- INCAGN 1876-202
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Keywords
- cervical cancer, endometrial cancer, gastric cancer (including stomach and gastroesophageal junction (GEJ)), esophageal cancer, hepatocellular carcinoma (HCC), melanoma (mucosal or cutaneous), Merkel cell carcinoma, mesothelioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to emergent data from another study and unrelated to safety.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCAGN01876 + Pembrolizumab + Epacadostat | Experimental | Drug: INCAGN01876, Drug: Epacadostat, Drug: PembrolizumabINCAGN01876 in combination with pembrolizumab and epacadostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
- Presence of measurable disease based on RECIST v1.1.
Key exclusion criteria (9 listed)
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCAGN01876In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1. | Drug | INCAGN01876 + Pembrolizumab + Epacadostat |
| EpacadostatAlso: INCB024360Epacadostat will be self-administered orally at the protocol-defined dose. | Drug | INCAGN01876 + Pembrolizumab + Epacadostat |
| PembrolizumabAlso: Keytruda®Pembrolizumab will be administered IV at the protocol-defined dose. | Drug | INCAGN01876 + Pembrolizumab + Epacadostat |
Primary outcome
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time frame: Screening through 60 days after end of treatment, up to approximately 18 months
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
5 secondary outcomes
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Overall Survival
Time frame: At 1 year and 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John N. Janik, MD study director
Incyte Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCAGN01876, Epacadostat and Pembrolizumab in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] (time frame: Screening through 60 days after end of treatment, up to approximately 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.